Overview of the export of western medicine preparations by local pharmaceutical companies

According to data provided by the China Chamber of Commerce for Import and Export of Medicines and Health Products, in the first quarter of 2018, China’s exports of Western medicines to the United States exceeded US$90 million. Among them, TOP 5 pharmaceutical companies Hengrui Medicine, Huahai Pharmaceutical The total exports of Nantong Lianya, Renfu Medicine and Qilu Pharmaceutical accounted for 67% of the total export of the preparations.

In the past three years, Huahai Pharmaceutical, Hengrui Medicine and Shijiazhuang Group have continued to occupy the position of TOP 5 of the annual formulation export. From the global generic drug market, the EU, the US and China are the world's top three generic drug consumption. Market, in recent years, Chinese local pharmaceuticals enterprise The number of US ANDA approvals obtained has gradually increased, and the export of western medicine preparations has shown an upward trend.

According to reports, the domestic FDA's application for FDA's application can be traced back to the 1974 application of the People's Foucault Pharmaceuticals Mesobanmo tablets (withdrawn from the market). In 1979, Huahai Pharmaceutical also reported through the US 2. Bamo began the FDA's overseas reporting process.

As of August 20, Chinese local pharmaceutical companies have a total of 278 US ANDA approval numbers, including 255 official approval numbers and 23 pre-approval numbers.

TOP 9 pharmaceutical companies have a total of 243 articles, which is 87.4% of the total number of documents. Huahai Pharmaceutical, Renfu Pharmaceutical and Fosun Pharma include the top three, Nantong Lianya, and Hengrui Medicine. Column 4, 5th.

At present, there are more than 4,000 domestic API manufacturers and pharmaceutical manufacturers. drug Nearly 170,000 approvals were issued, of which more than 95% were generic drugs, including Western medicine generics and traditional Chinese medicine generics. Compared with 278 US ANDA approval numbers, the number of domestic pharmaceutical companies is still less than 40. Family.

In 2017, domestic pharmaceutical companies exported US$310 million to Western medicine preparations, accounting for less than 9% of total Western medicine exports. In the same year, China’s Western medicine bulk medicine exports totaled US$29.117 billion, in 2015 and 2016. Similarly, in China's western medicine export products, Western medicine raw materials are still the main products, and the scale of western medicine preparations is small.

278 ANDA symbols covered 216 dosage forms, of which the proportion of tablets exceeded 60%, the proportion of injections was 27.3%, and the proportions of inhalation solution, external solution, suspension, powder and powder were less than 1%. In general, there are fewer types of dosage forms for US export preparations.

In 2017, the FDA received 1,306 generic applications, and the number of approved ANDAs was 767. It is observed that in recent years, the FDA has strongly encouraged the declaration of generic drugs, and the review of generics ANDA has continued to accelerate; Most of the types of products belong to the competing products of similar generic drugs.

In the future, in the US market where multiple competing products exist at the same time, competition will further intensify, market prices will continue to be lowered by new entrants, and the price of generic drugs will be lower, which is the proportion of generic prescriptions and sales in the past five years. The change in the proportion of consumption can be reflected: From 2013 to 2017, the proportion of prescriptions for generic drugs in the US market gradually increased from 86.5% to 90.3%. Conversely, the market share of generic drugs accounted for 28.7%. Dropped to 23%. This involves a variety of factors, the price of generic drugs is undoubtedly an important factor.

For most of the generic drug varieties that continue to have latecomers entering, the intensification of competition is inevitable. However, for the first generic drug or the patent challenge, the variety can be enjoyed by the current market policy in the US market, and then obtain a considerable profit. .

Successfully approved drugs can be sold on the day the original drug patent expires, and have a 180-day market exclusivity; patent-successful generics can obtain exclusive market exclusivity. In either case, in the market The generics during the exclusive period have superior market pricing rights and sales expectations.

November 2014, Hengrui medicine Production of cyclophosphamide for injection USP (United States Pharmacopoeia) standard The first generic drug was approved by the FDA and officially sold in the US market. In 2017, the overseas income of Hengrui Pharmaceuticals Nationalization was 637 million yuan. The main contribution of this performance came from the approval of this first imitation drug in the US market. In February, Hengrui Pharmaceuticals received the FDA approval for the application of desflurane ANDA, which is the second first generic drug listed in the United States after cyclophosphamide. The approval of these two imitation drugs for the future internationalization of Hengrui Medicine The growth of performance has an unusual meaning.

In addition to the two first generic drugs, on August 21, 2017, Huahai Pharmaceutical's paroxetine capsules were officially approved by the FDA, becoming the first generic drug in China to challenge the PIV patent challenge. Paroxetine capsules were approved through patent challenges. Obtaining the first generic drug qualification in the US market will not only win considerable profits for Huahai, but also provide important technical support for the listing of Huahai's follow-up products.